The Effect of Clear Masks in Improving Patient Relationships

NCT04595695 | Completed DMC

• 1 other identifier: 20-2229
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

To evaluate the effect of wearing masks that hide a surgeon's facial features versus one that shows them. New patients with no prior relationship with the surgeon will be asked questions regarding communication and trust with the surgeon.

Conditions

Communication; Trust; Covid19; Surgery

Keywords

Masks

Outcome Measures

Primary Outcomes (4)

• Patient Mask Preference Quantitative

  Using a Likert scale question evaluating patient preference for the type of mask (What was your impression of the surgeon's mask? "Did not like the mask", "somewhat did not like the mask", "somewhat liked the mask", "completely liked the mask", scored as 1 to 4 with higher score indicating greater preference).

  During 1-minute survey assessed immediately after clinic visit completion

• Patient Mask Preference Qualitative

  Patients will be asked for their comments about the surgeon's mask and these will be immediately transcribed.

  During 1-minute survey assessed immediately after clinic visit completion

• Patient Survey Scores Evaluating Surgeon Communication Skills

  Using Likert scale questions evaluating patient perception of surgeon communication, taken from the Clinician and Group Consumer Assessment of Healthcare Providers and Systems (CG-CAHPS) healthcare survey, each scored 1-4 with higher number indicating greater communication skills, from "not at all", "somewhat", "mostly" to "completely". This will include 6 questions evaluating communication skills with identical answer choices. Each participants total score will range from 6 to 24 with higher indicating better communication skills.

  During 1-minute survey assessed immediately after clinic visit completion

• Patient Survey Scores Describing Trust in the Surgeon

  Using Likert scale questions evaluating patient trust of the surgeon, asked, "How comfortable do you feel trusting this surgeon's decisions". Answer choices are score 1 - 4 with 4 indicating great trust, from "Completing uncomfortable", "somewhat uncomfortable", "somewhat comfortable", "completely comfortable"

  During 1-minute survey assessed immediately after clinic visit completion

Study Arms (2)

Transparent Mask

EXPERIMENTAL

Surgeons will be provided a transparent mask for use during in-person clinic visits with a new patient. Otherwise, visits will be conducted as per usual and the patient will be surveyed immediately after the visit.

Behavioral: Transparent mask

Covered Mask

ACTIVE COMPARATOR

Surgeons will be instructed to wear a typical, covered mask for the in-person clinic visit with a new patient. The visit will be conducted as it typically would, and the patient will be surveyed immediately after the visit.

Behavioral: Typical surgical covered mask

Interventions

Transparent mask BEHAVIORAL

A transparent mask worn by the surgeons in customary fashion will be used.

Also known as: ClearMask

Transparent Mask

Typical surgical covered mask BEHAVIORAL

A standard covered surgical mask worn by the surgeons in in customary fashion will be used.

Also known as: Halyard

Covered Mask

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Faculty within Department of Surgery at the University of North Carolina at Chapel Hill
• Must be English speaking
• Plans to see new in person visits in clinic

You may not qualify if:

• None
• At least 18 years old
• Can understand and speak English without the use of an interpreter
• Has capacity to make independent medical decisions
• Has a prior relationship with the surgeon
• Has symptoms of a respiratory infection (cough, shortness of breath, fever)

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27514, United States

Location

Related Publications (1)

• Kratzke IM, Rosenbaum ME, Cox C, Ollila DW, Kapadia MR. Effect of Clear vs Standard Covered Masks on Communication With Patients During Surgical Clinic Encounters: A Randomized Clinical Trial. JAMA Surg. 2021 Apr 1;156(4):372-378. doi: 10.1001/jamasurg.2021.0836.

  PMID: 33704389 DERIVED

MeSH Terms

Conditions

Communication; COVID-19

Condition Hierarchy (Ancestors)

Behavior; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Ian Kratzke, MD

  University of North Carolina at Chapel Hill Department of Surgery

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients will not know that their surgeon is participating in a research study. Visits will be completed as they typically would with the surgeon wearing a mask.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomized into typical covered mask versus transparent mask worn by the surgeon.

Study Record Dates

• First Submitted: October 14, 2020
• First Posted: October 20, 2020
• Study Start: September 3, 2020
• Primary Completion: November 12, 2020
• Study Completion: December 14, 2020
• Last Updated: January 14, 2021

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)